Michigan officials announce $100,000 in fines for South Lyon pharmacy

6:40 PM, April 10, 2014

Detroit Free Press Staff Writer

Michigan Attorney General Bill Schuette announced Thursday that $100,000 in fines and other penalties have been levied against a South Lyon pharmacy that distributed tainted injections.

The Specialty Medicine Compounding Pharmacy’s license also has been permanently suspended, state officials said. And the individual pharmacist’s license of its owner, Kenny Walkup Jr., has been revoked for three years.

The sanctions stem from the discovery last October of mold particles in what was supposed to be a sterile dextrose solution that the pharmacy had mixed and given to Henry Ford Hospital. No illnesses have been linked to the solution.

“Michigan citizens trust pharmacists to follow the laws designed to keep consumers safe, and these sanctions send the message that we’re serious about public safety and welfare,” Schuette said in a news release.

He made the announcement with Steve Arwood, director of the state’s Department of Licensing and Regulatory Affairs.

Schuette said the pharmacy was acting like a drug manufacturer by distributing large amounts of medicine to hospitals and clinics, but it was only licensed to fill individual prescriptions for patients.

Shortly after the tainted solution was discovered, Schuette filed a complaint against the pharmacy. The pharmacy closed and Walkup’s license was suspended.

At a hearing in November before an administrative law judge, Assistant Michigan Attorney General Kelly Elizondo argued that Walkup had applied for a manufacturer’s license that would allow him to fill general orders for hospitals or other medical facilities. But she said when he filled the Henry Ford order, he was licensed only to fill patient-specific prescriptions, not perform compounding in bulk.

Robert Iwrey, Walkup’s lawyer, said at the time that regulations allowed pharmacists with his license to provide the service if it’s less than 5% of the pharmacy’s business. He also said that while inspectors may have found some faulty practices, there was no proof that the contamination happened at the pharmacy.

Iwrey did not immediately return a message seeking comment.

Inspectors for the state and the Food and Drug Administration testified that the pharmacy was not following proper procedures to ensure products were sterile.

The sanctions were outlined in a consent order approved by the Michigan Board of Pharmacy Disciplinary Subcommittee, officials said. Of the $100,000 in fines, half is for the pharmacy and the other half for Walkup.

At the end of the three-year revocation period, Walkup’s license will not automatically be reinstated, according to officials. Instead, he would have to apply for a new license and convince the board of pharmacy to issue it.

Schuette said he is reviewing whether additional legal action against the pharmacy is warranted.